MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-10 for SMOKE EVACUATION HIGH-FLOW TUBE SET 0620050250 manufactured by W.o.m. World Of Medicine Gmbh.
[144703945]
When smoke evacuation high-flow tube set was plugged in, error message "tube set invalid" was received. We tried to take the tube set out and reinsert it as well as restart the insufflation system and continued to receive the same message. Got a new tube set and it worked.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8599383 |
| MDR Report Key | 8599383 |
| Date Received | 2019-05-10 |
| Date of Report | 2019-04-10 |
| Date of Event | 2019-03-26 |
| Report Date | 2019-04-10 |
| Date Reported to FDA | 2019-04-10 |
| Date Reported to Mfgr | 2019-05-10 |
| Date Added to Maude | 2019-05-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMOKE EVACUATION HIGH-FLOW TUBE SET |
| Generic Name | INSUFFLATOR, ENDOSCOPIC VESSEL HARVESTING |
| Product Code | OSV |
| Date Received | 2019-05-10 |
| Model Number | 0620050250 |
| Lot Number | 4015556 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | W.O.M. WORLD OF MEDICINE GMBH |
| Manufacturer Address | 4531 36TH ST. ORLANDO FL 32811 US 32811 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-10 |